Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study: protocol of a pragmatic clinical effectiveness study to improve birth outcomes in Ethiopia

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Abstract

Introduction

The WHO Nutrition Target aims to reduce the global prevalence of low birth weight by 30% by the year 2025. The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study will test the impact of packages of pregnancy interventions to enhance maternal nutrition and infection management on birth outcomes in rural Ethiopia.

Methods and analysis

ENAT is a pragmatic, open-label, 2×2 factorial, randomised clinical effectiveness study implemented in 12 rural health centres in Amhara, Ethiopia. Eligible pregnant women presenting at antenatal care (ANC) visits at <24 weeks gestation are enrolled (n=2400). ANC quality is strengthened across all centres. Health centres are randomised to receive an enhanced nutrition package (ENP) or standard nutrition care, and within each health centre, individual women are randomised to receive an enhanced infection management package (EIMP) or standard infection care. At ENP centres, women receive a regular supply of adequately iodised salt and iron–folate (IFA), enhanced nutrition counselling and those with mid-upper arm circumference of <23 cm receive a micronutrient fortified balanced energy protein supplement (corn soya blend) until delivery. In standard nutrition centres, women receive routine counselling and IFA. EIMP women have additional screening/treatment for urinary and sexual/reproductive tract infections and intensive deworming. Non-EIMP women are managed syndromically per Ministry of Health Guidelines. Participants are followed until 1-month post partum, and a subset until 6 months. The primary study outcomes are newborn weight and length measured at <72 hours of age. Secondary outcomes include preterm birth, low birth weight and stillbirth rates; newborn head circumference; infant weight and length for age z-scores at birth; maternal anaemia; and weight gain during pregnancy.

Ethics and dissemination

ENAT is approved by the Institutional Review Boards of Addis Continental Institute of Public Health (001-A1-2019) and Mass General Brigham (2018P002479). Results will be disseminated to local and international stakeholders.

Registration number

ISRCTN15116516.

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Most cited references 48

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National, regional, and worldwide estimates of low birthweight in 2015, with trends from 2000: a systematic analysis

Hannah Blencowe, Julia Krasevec, Mercedes de Onis … (2019)

Summary Background Low birthweight (LBW) of less than 2500 g is an important marker of maternal and fetal health, predicting mortality, stunting, and adult-onset chronic conditions. Global nutrition targets set at the World Health Assembly in 2012 include an ambitious 30% reduction in LBW prevalence between 2012 and 2025. Estimates to track progress towards this target are lacking; with this analysis, we aim to assist in setting a baseline against which to assess progress towards the achievement of the World Health Assembly targets. Methods We sought to identify all available LBW input data for livebirths for the years 2000–16. We considered population-based national or nationally representative datasets for inclusion if they contained information on birthweight or LBW prevalence for livebirths. A new method for survey adjustment was developed and used. For 57 countries with higher quality time-series data, we smoothed country-reported trends in birthweight data by use of B-spline regression. For all other countries, we estimated LBW prevalence and trends by use of a restricted maximum likelihood approach with country-level random effects. Uncertainty ranges were obtained through bootstrapping. Results were summed at the regional and worldwide level. Findings We collated 1447 country-years of birthweight data (281 million births) for 148 countries of 195 UN member states (47 countries had no data meeting inclusion criteria). The estimated worldwide LBW prevalence in 2015 was 14·6% (uncertainty range [UR] 12·4–17·1) compared with 17·5% (14·1–21·3) in 2000 (average annual reduction rate [AARR] 1·23%). In 2015, an estimated 20·5 million (UR 17·4–24·0 million) livebirths were LBW, 91% from low-and-middle income countries, mainly southern Asia (48%) and sub-Saharan Africa (24%). Interpretation Although these estimates suggest some progress in reducing LBW between 2000 and 2015, achieving the 2·74% AARR required between 2012 and 2025 to meet the global nutrition target will require more than doubling progress, involving both improved measurement and programme investments to address the causes of LBW throughout the lifecycle. Funding Bill & Melinda Gates Foundation, The Children's Investment Fund Foundation, United Nations Children's Fund (UNICEF), and WHO.

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Mortality risk in preterm and small-for-gestational-age infants in low-income and middle-income countries: a pooled country analysis.

Rogelio González Sarmiento, Cesar Victora, Cláudia F M Silveira … (2013)

Babies with low birthweight (<2500 g) are at increased risk of early mortality. However, low birthweight includes babies born preterm and with fetal growth restriction, and not all these infants have a birthweight less than 2500 g. We estimated the neonatal and infant mortality associated with these two characteristics in low-income and middle-income countries. For this pooled analysis, we searched all available studies and identified 20 cohorts (providing data for 2,015,019 livebirths) from Asia, Africa, and Latin America that recorded data for birthweight, gestational age, and vital statistics through 28 days of life. Study dates ranged from 1982 through to 2010. We calculated relative risks (RR) and risk differences (RD) for mortality associated with preterm birth (<32 weeks, 32 weeks to <34 weeks, 34 weeks to <37 weeks), small-for-gestational-age (SGA; babies with birthweight in the lowest third percentile and between the third and tenth percentile of a US reference population), and preterm and SGA combinations. Pooled overall RRs for preterm were 6·82 (95% CI 3·56-13·07) for neonatal mortality and 2·50 (1·48-4·22) for post-neonatal mortality. Pooled RRs for babies who were SGA (with birthweight in the lowest tenth percentile of the reference population) were 1·83 (95% CI 1·34-2·50) for neonatal mortality and 1·90 (1·32-2·73) for post-neonatal mortality. The neonatal mortality risk of babies who were both preterm and SGA was higher than that of babies with either characteristic alone (15·42; 9·11-26·12). Many babies in low-income and middle-income countries are SGA. Preterm birth affects a smaller number of neonates than does SGA, but is associated with a higher mortality risk. The mortality risks associated with both characteristics extend beyond the neonatal period. Differentiation of the burden and risk of babies born preterm and SGA rather than with low birthweight could guide prevention and management strategies to speed progress towards Millennium Development Goal 4--the reduction of child mortality. Bill & Melinda Gates Foundation. Copyright © 2013 Elsevier Ltd. All rights reserved.

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Comparison of the World Health Organization (WHO) Child Growth Standards and the National Center for Health Statistics/WHO international growth reference: implications for child health programmes.

Mercedes de Onis, Adelheid W Onyango, Elaine Borghi … (2006)

To compare growth patterns and estimates of malnutrition based on the World Health Organization (WHO) Child Growth Standards ('the WHO standards') and the National Center for Health Statistics (NCHS)/WHO international growth reference ('the NCHS reference'), and discuss implications for child health programmes. Secondary analysis of longitudinal data to compare growth patterns (birth to 12 months) and data from two cross-sectional surveys to compare estimates of malnutrition among under-fives. Bangladesh, Dominican Republic and a pooled sample of infants from North America and Northern Europe. Respectively 4787, 10 381 and 226 infants and children. Healthy breast-fed infants tracked along the WHO standard's weight-for-age mean Z-score while appearing to falter on the NCHS reference from 2 months onwards. Underweight rates increased during the first six months and thereafter decreased when based on the WHO standards. For all age groups stunting rates were higher according to the WHO standards. Wasting and severe wasting were substantially higher during the first half of infancy. Thereafter, the prevalence of severe wasting continued to be 1.5 to 2.5 times that of the NCHS reference. The increase in overweight rates based on the WHO standards varied by age group, with an overall relative increase of 34%. The WHO standards provide a better tool to monitor the rapid and changing rate of growth in early infancy. Their adoption will have important implications for child health with respect to the assessment of lactation performance and the adequacy of infant feeding. Population estimates of malnutrition will vary by age, growth indicator and the nutritional status of index populations.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Paediatr Open

Journal ID (iso-abbrev): BMJ Paediatr Open

Journal ID (hwp): bmjpo

Journal ID (publisher-id): bmjpo

Title: BMJ Paediatrics Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2399-9772

Publication date Collection: 2022

Publication date (Electronic): 13 January 2022

Volume: 6

Issue: 1

Electronic Location Identifier: e001327

Affiliations

[1 ]departmentDepartment of Pediatric Newborn Medicine, Global Advancement of Infants and Mothers , Brigham and Women's Hospital , Boston, Massachusetts, USA

[2 ]Harvard Medical School , Boston, Massachusetts, USA

[3 ]Addis Continental Institute of Public Health , Addis Ababa, Ethiopia

[4 ]departmentDepartment of International Health , Johns Hopkins Bloomberg School of Public Health , Baltimore, Maryland, USA

[5 ]Amhara Public Health Institute , Bahir Dar, Ethiopia

[6 ]departmentDepartment of Medical Critical Care , Boston Children's Hospital , Boston, Massachusetts, USA

[7 ]departmentDepartment of Epidemiology , Harvard TH Chan School of Public Health , Boston, Massachusetts, USA

[8 ]departmentDepartments of Nutrition and Global Health and Population , Harvard TH Chan School of Public Health , Boston, Massachusetts, USA

[9 ]departmentDivision of Global Health Equity , Brigham and Women's Hospital , Boston, Massachusetts, USA

[10 ]Felege Hiwot Comprehensive Referral Hospital , Bahir Dar, Ethiopia

[11 ]departmentDepartment of Obstetrics and Gynecology , Beth Israel Deaconess Medical Center , Boston, Massachusetts, USA

[12 ]departmentDepartment of Infectious Disease Epidemiology , London School of Hygiene and Tropical Medicine , London, UK

[13 ]departmentDebretabor Referral Hospital , Amhara Regional Health Bureau , Bahir Dar, Ethiopia

Author notes

[Correspondence to ] Dr Anne CC Lee; alee6@ 123456bwh.harvard.edu ; Professor Yemane Berhane; yemaneberhane@ 123456addiscontinental.edu.et

Author information

Anne CC Lee http://orcid.org/0000-0003-2654-9862

Grace J Chan http://orcid.org/0000-0002-2716-1643

Article

Publisher ID: bmjpo-2021-001327

DOI: 10.1136/bmjpo-2021-001327

PMC ID: 8762145

PubMed ID: 36053580

SO-VID: 1ddb4e58-65ae-48ed-b779-00e22def40b5

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

History

Date received : 21 October 2021

Date accepted : 07 November 2021

Funding

Funded by: Bill & Melinda Gates Foundation;

Award ID: OPP1184363

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Keywords: neonatology,growth

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Keywords: neonatology, growth

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Abstract

Introduction

Methods and analysis

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Animal models of intrauterine growth restriction (IUGR)

Most cited references 48

National, regional, and worldwide estimates of low birthweight in 2015, with trends from 2000: a systematic analysis

Mortality risk in preterm and small-for-gestational-age infants in low-income and middle-income countries: a pooled country analysis.

Comparison of the World Health Organization (WHO) Child Growth Standards and the National Center for Health Statistics/WHO international growth reference: implications for child health programmes.

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